Roche ACCU-CHEK Inform II User manual

Category
Measuring, testing & control
Type
User manual
Accu-Chek
®
Inform II
BLOOD GLUCOSE MONITORING SYSTEM
Operator’s Manual
2 0 8938318001 (01) 2020-03 EN-CAN • Accu-Chek Inform II Operator’s Manual Version 4.1
Revision History
Manual content version Revision date Changes
Version 1.0 2008-01 New document, international launch with document
0 4807839001 (01) EN 2008-01.
Version 2.0 2009-08 Update, new SW version 02.00; creation document
versions 0 5956200001 (01) 2009-08 EN-CAN/
0 5956218001 (01) 2009-08 FR-CAN for Canada
Version 3.0 2010-09 Update, new SW version 03.00. This manual version
not available in Canada.
Version 4.0 2012-11 Update, new SW version 03.04 (OTS, OTE), revision
Cleaning/Disinfection section; misc. editorial revi-
sions; international launch with document
0 4807839001 (04) 2012-11 EN. This document not
available in Canada.
Version 4.0 2013-11 Creation documents 0 5956200001 (02) 2013-11
EN-CAN/ 0 5956218001 (02) 2013-11 FR-CAN
containing Canada-specific changes. Additionally,
implemented information on barcode symbologies;
misc. corrections/amendments to v4.0 international.
Version 4.1 2020-03 Update of complete manual to cover new features of
SW versions 03.05, 03.06 and 03.07. New material
number. Update of C&D information.
0 8938318001 (01) 2020-03 EN-CAN
Operators Manual
Version 4.1
A
A
CCU-
CCU-C
HEK
HEK
®
Inform II System
4 0 8938318001 (01) 2020-03 EN-CAN • Accu-Chek Inform II Operator’s Manual Version 4.1
© 2008-2020, Roche Diagnostics. All rights reserved.
The contents of this document, including all graphics, are the property of Roche Diagnostics. No part of this
document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any
purpose, without the express written permission of Roche Diagnostics. Roche Diagnostics has made every
reasonable effort to ensure that all the information contained in this manual is correct at the time of printing.
However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of
ongoing product development.
Please send questions or comments about this manual to your local Roche representative.
ACCU-CHEK, ACCU-CHEK INFORM, ACCU-CHEK PERFORMA and COBAS are trademarks of Roche.
All other trademarks are the property of their respective owners.
The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance.
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On the packaging, on the identification plate of the meter, the battery pack, the base unit, or the code key
reader you may encounter the following symbols, shown here with their meaning:
Caution, consult accompanying documents. Refer to safety-related notes in the instructions
for use accompanying this product.
Temperature limitation (Store at)
Manufacturer
Catalog number
In vitro diagnostic medical device
This product fulfills the requirements of the European Directives 98/79/EC on in vitro
diagnostic medical devices and 1999/5/EC on radio and telecommunications terminal
equipment (R&TTE).
This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada.
The compliance mark indicates that the product complies with the applicable standard and
establishes a traceable link between the equipment and the manufacturer, importer or their
agent responsible for compliance and for placing it on the Australian and New Zealand
market.
The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accordance
with UL 61010-1 and CAN/CSA-C22.2 No. 61010-1)
Power supply connection (Base Unit, Base Unit Light: legacy version)
Power supply connection (Base Unit, Base Unit Light) or
Power supply connection (Base Unit, Base Unit Light)
IVD
7.5V 1.7A
12V 1.25
A
12V 1.50
A
6 0 8938318001 (01) 2020-03 EN-CAN • Accu-Chek Inform II Operator’s Manual Version 4.1
What is new in publication version 4.1?
This section provides an overview of all major changes
from Operator’s Manual version 4.0 to version 4.1. Dele-
tions or minor corrections are not listed.
SW 03.05 Description of new features SW 03.05 and amendments
from the supplement (English master document
0 7155271001 (02) 2014-10 EN and all derived transla-
tions) have been implemented.
The hourglass icon appears after the test strip has
been inserted to indicate that the meter is checking
the test strip. This new workflow applies whenever
you perform a test, whether patient glucose test,
control test, proficiency, or linearity. For an exam-
ple, see page 59.
With SW 03.05 the Accu-Chek Inform II meter soft-
ware supports more languages in the user inter-
face. Please contact your local Roche organization
for more information about the availablitly of lan-
guage packs.
SW 03.06 Communication via WLAN can be encrypted in the same
way as wired communication between base unit and
DMS. This option can only be configured via a DMS. See
page 168.
SW 03.07 Based on customer feedback, new features have been
added and existing ones improved.
Configurable QC lockout. See page 56.
Patient ID validation: check against length. See
section A.1 “Table of configuration options”. See
page 166.
The date of birth (DOB) can now be displayed on
patient glucose test screens. See page 58.
Separate QC and Patient comment settings. See
page 79.
In case of an automatic power-off, results will be
automatically flagged with a standard comment.
See page 22.
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Improvement of data privacy. Automatic deletion of
outdated patient data, see page 144.
Reworked displaying error codes (see page 149f):
Replaced the numbers by letters.
Removed codes in decision messages.
New layout safety messages The presentation of safety messages in this manual has
been updated throughout. See section 1.2 “Important
safety instructions and additional information”.
Test principle Description of the test principle used by the meter. See
page 17.
Patient Glucose Testing Additional information on obtaining a blood sample has
been added. See page 60.
Barcode handling Additional information on working with barcodes has
been added. See page 172.
Corrections
Technical data of meter and code key reader have
been updated, see section 12.1 “Technical data”.
WLAN security settings have been updated, see
section A.1 “Table of configuration options”.
Accu-Chek Inform II Base Unit The Accu-Chek Inform II Base Unit and Base Unit
Light with new hardware and software
(REF 07671717190 and REF 08376824190) have
replaced the legacy versions (REF 05060290001 and
REF 05920353001), and are described in section1.6
“Overview of the Accu-Chek Inform II Base Unit”.
An overview of the legacy versions of Accu-Chek
Inform II Base Unit and Base Unit Light and the cor-
responding technical information have been moved
to Appendix E.
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What is new in publication version 4.1? 6
SW 03.05................................................................................................................................................ 6
SW 03.06................................................................................................................................................ 6
SW 03.07................................................................................................................................................ 6
New layout safety messages.......................................................................................................... 7
Test principle ....................................................................................................................................... 7
Patient Glucose Testing ................................................................................................................... 7
Barcode handling............................................................................................................................... 7
Corrections ........................................................................................................................................... 7
Accu-Chek Inform II Base Unit..................................................................................................... 7
1 Introduction 15
1.1
Before you start......................................................................................................................................... 15
Intended use ...................................................................................................................................... 15
Important information regarding use ....................................................................................... 15
If you need help................................................................................................................................ 16
Note on the use of “base unit” in this manual...................................................................... 16
Note on illustrations in this manual .......................................................................................... 16
What can the system do for you? .............................................................................................. 17
Test principle ..................................................................................................................................... 17
1.2 Important safety instructions and additional information......................................................... 18
Important information regarding safety................................................................................... 19
Disposal of the system ................................................................................................................... 21
Product safety.................................................................................................................................... 21
General care....................................................................................................................................... 21
Accessory box ................................................................................................................................... 21
Meter .................................................................................................................................................... 22
Power off meter ................................................................................................................................ 22
Automatic power-off....................................................................................................................... 22
Battery Pack ....................................................................................................................................... 22
Touchscreen....................................................................................................................................... 24
Laser scanner .................................................................................................................................... 25
Electromagnetic compatibility (EMC)....................................................................................... 25
Electrostatic discharge (ESD)...................................................................................................... 26
Wireless connectivity (RF card) .................................................................................................. 26
Radiofrequency radiation exposure information.................................................................. 27
Local Area Network: protection from unauthorized access ............................................ 29
Wired network connection ........................................................................................................... 29
Note on systems with older hardware ..................................................................................... 31
1.3 System components................................................................................................................................ 33
1.4 Overview of the meter ............................................................................................................................ 35
1.5 Overview of the code key reader ....................................................................................................... 36
1.6 Overview of the Accu-Chek Inform II Base Unit .......................................................................... 37
1.7 Overview of the Accu-Chek Inform II Base Unit Hub................................................................. 39
1.8 Overview of the accessory box ........................................................................................................... 40
1.9 Reagents and consumables................................................................................................................. 40
1.10 Instructions for initial setup.................................................................................................................. 41
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2 Powering Up and Entering an Operator ID 43
2.1 Powering up the meter........................................................................................................................... 43
Adjusting the display ...................................................................................................................... 44
Adjusting the display on meters with older hardware ....................................................... 44
Enabling/disabling wireless connectivity (RF card) ............................................................ 45
Closing startup .................................................................................................................................. 46
2.2 Entering the operator ID........................................................................................................................ 46
Entering an operator ID with barcode scanner .................................................................... 47
Entering the operator ID manually............................................................................................. 48
Entering a password ....................................................................................................................... 48
3 Patient Glucose Testing 49
3.1
Information regarding blood glucose testing ................................................................................ 49
Preparing to test ............................................................................................................................... 49
3.2 Performing a patient glucose test...................................................................................................... 51
Overview of test procedure .......................................................................................................... 51
Entering or selecting the patient ID .......................................................................................... 51
Entering the patient ID manually................................................................................................ 53
Selecting the patient ID from a list............................................................................................ 54
Entering a patient ID with barcode scanner .......................................................................... 55
Confirming or selecting the test strip lot................................................................................. 56
Patient identification information............................................................................................... 58
Inserting test strips .......................................................................................................................... 59
Obtaining a blood sample............................................................................................................. 60
Applying a blood sample............................................................................................................... 61
Results screen ................................................................................................................................... 62
Adding comments............................................................................................................................ 65
Additional Patient Test ................................................................................................................... 67
4 Glucose Control Testing 69
4.1
Information regarding glucose control tests.................................................................................. 69
Glucose control testing intervals................................................................................................ 70
Information stored during glucose control testing.............................................................. 71
Control solutions............................................................................................................................... 71
Preparing to run a glucose control test ................................................................................... 71
4.2 Performing glucose control tests ....................................................................................................... 72
Overview of test procedure .......................................................................................................... 72
Starting a glucose control test .................................................................................................... 73
Confirming or selecting the lot number for control solutions ......................................... 74
Confirming or selecting the test strip lot................................................................................. 75
Inserting test strips .......................................................................................................................... 76
Applying the control solution....................................................................................................... 77
Results screen ................................................................................................................................... 78
Performing a STAT test .................................................................................................................. 80
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5 Review Results 81
5.1 Displaying test results from the memory ........................................................................................ 81
Information stored in data records for test results.............................................................. 81
List of results stored in the memory ......................................................................................... 81
6 Storing Test Strip, Control Solution, and Linearity Solution
Information in the Meter 83
6.1
Storing information about test strips................................................................................................ 83
Transferring code key information to the meter .................................................................. 84
Editing test strip data...................................................................................................................... 87
6.2 Storing control solution information ................................................................................................. 90
Entering the lot number of the control solution ................................................................... 90
Selecting a stored lot number as the current lot number ................................................ 93
6.3 Storing linearity test information........................................................................................................ 95
Entering the lot number of the linearity test.......................................................................... 95
Selecting a stored lot number as the current lot number ................................................ 97
7 Linearity Testing 99
7.1
Information regarding linearity tests................................................................................................. 99
Linearity testing intervals ........................................................................................................... 100
Information stored during linearity testing.......................................................................... 100
Linearity test kit ............................................................................................................................. 101
Preparing to run a linearity test ............................................................................................... 101
7.2 Performing a linearity test.................................................................................................................. 102
Overview of test procedure ....................................................................................................... 102
Starting a linearity test ................................................................................................................ 102
Confirming or selecting the lot number for linearity test kits....................................... 103
Confirming or selecting the test strip lot.............................................................................. 103
Inserting test strips....................................................................................................................... 104
Applying a linearity test sample .............................................................................................. 105
Results screen ................................................................................................................................ 106
8 Proficiency Testing 107
8.1
Information regarding proficiency tests ....................................................................................... 107
Information stored during proficiency testing.................................................................... 108
Preparing a proficiency test ...................................................................................................... 108
8.2 Performing a proficiency test............................................................................................................ 109
Overview of test procedure ....................................................................................................... 109
Starting a proficiency test.......................................................................................................... 109
Entering the proficiency sample ID........................................................................................ 110
Confirming or selecting the test strip lot.............................................................................. 110
Inserting test strips....................................................................................................................... 111
Applying a proficiency sample................................................................................................. 112
Results screen ................................................................................................................................ 113
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9 Initial Startup 115
9.1 Connecting the base unit .................................................................................................................. 115
9.2 Installing or replacing the battery pack ....................................................................................... 117
Removing the battery pack........................................................................................................ 118
Installing the battery pack ......................................................................................................... 119
9.3 Docking the meter ................................................................................................................................ 122
9.4 Setting the date and time................................................................................................................... 124
9.5 Beeper options ....................................................................................................................................... 125
10 Maintenance and Care 127
10.1
Conditions for storage and shipping ............................................................................................. 127
General operating conditions ................................................................................................... 127
Shipping............................................................................................................................................ 128
Storage .............................................................................................................................................. 129
10.2 Cleaning/disinfecting the Accu-Chek Inform II system.......................................................... 129
Guide to cleaning and disinfecting the Accu-Chek Inform II system ...................... 130
Difference between cleaning and disinfecting .................................................................. 130
When to clean/disinfect.............................................................................................................. 130
Approved cleaning and disinfecting products................................................................... 131
Technical Assistance ................................................................................................................... 132
What to clean/disinfect............................................................................................................... 133
How to clean/disinfect ................................................................................................................ 135
Cleaning the barcode scanner window................................................................................ 137
Cleaning/disinfecting the base unit ....................................................................................... 137
Cleaning/disinfecting the accessory box ............................................................................. 138
10.3 Logging maintenance activities....................................................................................................... 139
10.4 Diagnostics view.................................................................................................................................... 141
10.5 Deleting patient data ........................................................................................................................... 143
Manual deletion............................................................................................................................. 143
Automatic deletion........................................................................................................................ 144
11 Troubleshooting 145
Errors and unusual behavior without error messages
.................................................... 145
Pop-up messages.......................................................................................................................... 149
Meter reset ...................................................................................................................................... 151
12 General Product Information 153
12.1
Technical data ....................................................................................................................................... 153
12.2 Further Information............................................................................................................................... 157
Ordering ........................................................................................................................................... 157
Accu-Chek Inform II Operator’s Manual and Quick Reference Guide..................... 159
Reagents and Solutions.............................................................................................................. 159
Product limitations........................................................................................................................ 159
Warranty ........................................................................................................................................... 159
Information about software licenses...................................................................................... 160
Contact Roche................................................................................................................................ 160
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A Appendix 161
A.1 Table of configuration options ......................................................................................................... 161
A.2 Example of barcode symbologies ................................................................................................... 172
B Appendix 175
B.1
Option: Wireless network (WLAN) ................................................................................................. 175
Preliminary note............................................................................................................................. 175
Background..................................................................................................................................... 175
Technical implementation.......................................................................................................... 176
Location and type of RF card ................................................................................................... 177
RF specific functionalities and effective performance claims...................................... 178
C Supplement for Other Test Entry 181
C.1
Before you start...................................................................................................................................... 181
Description ...................................................................................................................................... 181
C.2 Overview of Other Test Entry (OTE) ............................................................................................... 182
Introduction..................................................................................................................................... 182
C.3 Recording Other Patient Tests ......................................................................................................... 185
C.4 Recording Other Control Tests ........................................................................................................ 192
Introduction..................................................................................................................................... 192
Other Control Testing Intervals................................................................................................ 192
Stored Control Information........................................................................................................ 192
Warning messages ....................................................................................................................... 198
C.5 Reviewing Other Test Results........................................................................................................... 199
C.6 Other Test Entry Configuration Options ....................................................................................... 202
D Supplement for Observed Test Sequence 203
Observed Test Sequence (OTS)
............................................................................................... 203
Using the OTS function............................................................................................................... 204
E Appendix for Accu-Chek Inform II Base Unit and Base Unit Light
(legacy versions) 207
E.1
Overview of the base unit with older hardware......................................................................... 207
E.2 Connecting the base unit (legacy version) ................................................................................ 209
E.3 Cleaning/disinfecting the base unit (legacy version).............................................................. 209
E.4 Technical data ....................................................................................................................................... 210
Index 211
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Introduction • 1
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1 Introduction
1.1 Before you start
Intended use The Accu-Chek
®
Inform II system is intended for in vitro
diagnostic use in the quantitative determination of blood
glucose levels in venous, capillary, arterial, and neonatal
whole blood samples for monitoring blood glucose. This
product is for monitoring hypoglycemia in neonates
diagnosed with laboratory glucose methods. The system
is indicated for use by healthcare professionals. For
healthcare professionals, the system is a bedside unit that
can help you provide quality patient care by measuring
blood glucose and by automating the record keeping
associated with blood glucose and glucose control tests.
Important information regarding
use
Read this operator's manual, as well as the package
inserts for all relevant consumables, before using the
system for the first test.
You must configure the Accu-Chek Inform II system
according to your needs before initial use. You can con-
figure the system by using a suitable data management
system. Refer to Appendix A for configuration via a data
management system. The device may not be used in
screening for neonatal hypoglycemia.
Be sure to read the “Important safety instructions and
additional information” section in this chapter before
operating the system.
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If you need help Information about using the system, the screen menus and
performing a test can be found in this operator's manual.
Error messages that appear on-screen include informa-
tion or instructions on how to correct the error.
For all questions about the Accu-Chek Inform II system
that are not answered in this manual, contact your Roche
representative (see Chapter 12). In order to expedite
troubleshooting, please have ready your Accu-Chek
Inform II meter, its serial number, this manual, and all
related consumables when you call. If you suspect a com-
munication error beyond the meter, also have your
Accu-Chek Inform II Base Unit serial number ready to
help assist our customer care group in troubleshooting.
Note on the use of “base unit” in
this manual
Note on illustrations in this
manual
Unless otherwise specified, the term “base unit” refers
to both the Accu-Chek Inform II Base Unit and the
Accu-Chek Inform II Base Unit Light.
Illustrations in this manual show two different kinds of
hands:
Hand without glove Hand with glove
A dashed arrow between screen illustrations indicates
that some screens have been skipped in these
illustrations.
Introduction • 1
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What can the system do for you? The Accu-Chek Inform II system has the following
features and properties:
Perform patient blood glucose tests and glucose
control tests with control solution.
Automatically record all relevant data for the appli-
cation, which includes:
Time and date of test
IDs for operator, patient, and samples
Information about control solutions, test strips, and
linearity
Test results and comments
Record patient test results, quality control test
results and reagent information for certain off-
meter manual tests.
For purposes of quality assurance, information on
the following areas can be collected, stored, and
transferred:
Meters
Test strips
Glucose control solutions
Linearity solutions
Test results
Test principle An enzyme on the test strip converts the glucose in the
blood sample to gluconolactone. This reaction creates a
harmless DC electrical current that the meter interprets
and converts into a blood glucose result. The sample and
environmental conditions are also evaluated using AC
and DC signals.
For more details, refer to the test strip package insert.
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1.2 Important safety instructions and additional information
This section explains how safety-related messages and
information related to the proper handling of the system
are presented in the Accu-Chek Inform II manual. Please
read these passages carefully.
These symbols and signal words are used for specific
hazards:
The safety alert symbol alone (without a signal word)
promotes awareness to hazards which are generic or
directs the reader to related safety information.
WARNING
Indicates a hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION
Indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury.
NOTICE
Indicates a hazardous situation which, if not avoided, may
result in damage to the system.
Important information that is not safety relevant is
presented against a colored background (without a
symbol). Here you will find additional information on
correct use of the meter or useful tips.
Introduction • 1
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Important information regarding
safety
Operator qualification
Only trained healthcare professionals may operate the
Accu-Chek Inform II system. Operators must also have
received comprehensive instruction in the operation,
quality control, and care of the Accu-Chek Inform II
system.
WARNING
Protection against infection and blood-borne
pathogens
Healthcare professionals using the Accu-Chek Inform II
system to perform tests must be aware that any object
coming into contact with human blood is a potential
source of infection. Operators need to adhere to Standard
Precautions when handling or using the Accu-Chek
Inform II system. All parts of this system should be
considered potentially infectious and are capable of
transmitting blood-borne pathogens between patients
and between patients and healthcare professionals.
Use gloves. Wear a new pair of clean gloves for test-
ing each patient.
Wash hands thoroughly with soap and water before
putting on a new pair of gloves and performing the
next patient test.
Use an auto-disabling single-use lancing device for
each patient.
Dispose of used lancets in a sturdy sharps container
with lid.
Dispose of used test strips from patient and
proficiency tests according to your institution’s infec-
tion control policy.
Follow all health and safety regulations in force
locally.
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CAUTION
Allergy or injury caused by reagents and other
working solutions
Direct contact with reagents, detergents, cleaning/disin-
fection solutions, or other working solutions may cause
skin irritation or inflammation.
Always use protective gloves.
Observe the cautions given in the package inserts of
the reagents and cleaning/disinfection solutions.
If a reagent, control, linearity, or cleaning/disinfection
solution comes into contact with your skin, wash it off
immediately with water.
Follow all health and safety regulations in force
locally.
WARNING
Avoidance of electrical shock, fire, and explosions
Only use Roche original accessories (cables, power
supply units, battery packs, and spare parts). Third-
party cables, power supply units, and battery packs
can cause the battery pack to explode or the meter to
become damaged.
Do not use loose power sockets or damaged power
supply units, cables, plugs, or battery packs.
Do not short circuit the power supply unit, the base
unit charging contacts, or the battery pack.
Do not drop the Accu-Chek Inform II meter, the power
supply unit, or the battery pack and protect these
against shaking and vibrations.
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Roche ACCU-CHEK Inform II User manual

Category
Measuring, testing & control
Type
User manual

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